Cattle (beef and dairy cattle), sheep and goats.

Oesophagostomum spp.

Applied as recommended, the product prevents reinfestations with:

Parasite	Prolonged Activity
Dictyocaulus viviparus	Up to 28 days
Ostertagia ostertagi	Up to 28 days
Oesophagostomum radiatum	Up to 28 days
Cooperia punctata	Up to 28 days
Cooperia surnabada	Up to 28 days
Cooperia oncophora	Up to 28 days
Nematodirus helvetianus	Up to 14 days
Trichostrongylus colubriformis	Up to 21 days
Trichostrongylus axei	Up to 21 days
Haemonchus placei	Up to 21 days

For best results the veterinary medicinal product should be part of a programme to control both internal and external parasites of cattle based on the epidemiology of these parasites.

For best results the veterinary medicinal product should be part of a programme to control both internal and external parasites of sheep and goats based on the epidemiology of these parasites.

Do not use in other animal species. Avermectins can cause fatalities in dogs, especially Collies, Old English Sheepdogs and related breeds and crosses, and also in turtles/tortoises.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

For effective use, the product should not be applied to areas of the backline covered with mud or manure.

In cattle, rainfall before, during or after the application of the product, has been shown to have no impact on its efficacy. It also has been demonstrated that haircoat length has no impact on the product’s efficacy. The effect of rainfall and haircoat length on efficacy has not been evaluated in sheep and goats.

In order to limit cross-transfer of eprinomectin, treated animals should preferably be separated from untreated animals. Non-compliance with this recommendation may lead to residue violations in untreated animals and development of resistance to eprinomectin.

Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of infestation based on its epidemiological features, for each herd.

Repeated use for an extended period, particularly when using the same class of substances, increases the risk of resistance development. Within a herd, maintenance of susceptible refugia is essential to reduce that risk. Systematically applied interval-based treatment and treatment of a whole herd should be avoided. Instead, if feasible, only selected individual animals or subgroups should be treated (targeted selective treatment). This should be combined with appropriate husbandry and pasture management measures. Guidance for each specific herd should be sought from the responsible veterinarian.

Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

To date no resistance to eprinomectin (a macrocyclic lactone) has been reported in cattle while resistance to eprinomectin has been reported in goats and sheep within the EU. However, resistance to other macrocyclic lactones has been reported in nematode populations in cattle, sheep and goats within the EU, which may be associated with side-resistance to eprinomectin.

While mite and louse numbers decline rapidly following treatment, due to the feeding habits of some mites, in some cases several weeks may be required for complete eradication.

For external use only. The product should be applied only on healthy skin. To avoid secondary reactions due to the death of Hypoderma larvae in the oesophagus or in the spine, it is recommended to administer the product at the end of warble fly activity and before the larvae reach their resting sites.

People with known hypersensitivity to the active substance or to any of the excipients should avoid contact with the product.

This product may be irritating to skin and eyes. Avoid contact with eyes and skin.

Operators should wear rubber gloves, boots and waterproof coat when applying the product.

Should clothing become contaminated, remove as soon as possible and launder before re-use.

If accidental skin contact occurs, wash the affected area immediately with soap and water.

Should accidental eye exposure occur, flush eyes immediately with plenty of clean water. Should irritation persist, seek medical advice.

Do not ingest.

In case of accidental ingestion, rinse out mouth thoroughly with water, seek medical advice immediately and show the package insert or the label to the physician.

Do not smoke, eat or drink while handling the product.

Wash hands after use.

Eprinomectin is very toxic to dung fauna and aquatic organisms, is persistent in soils and may accumulate in sediments. The risk to aquatic ecosystems and dung fauna can be reduced by avoiding repeated use of eprinomectin (and products of the same anthelmintic class). In order to reduce the risk to aquatic ecosystems, treated animals should not have direct access to water bodies for two to five weeks after treatment.

Pruritus and alopecia have been observed in very rare cases, after the use of the veterinary medicinal product.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

Laboratory studies (rat, rabbit) have not produced any evidence of a teratogenic or embryotoxic effects due to the use of eprinomectin at therapeutic doses. Laboratory studies in cattle have not produced any evidence of a teratogenic or foetotoxic effect at the recommended therapeutic dose. The product can be used in dairy cattle during pregnancy and lactation.

The safety of eprinomectin during pregnancy in sheep and goats has not been tested. Use only according to the benefit/risk assessment of the responsible veterinarian in these species.

No interactions with other medicines and no other forms of interactions are known. Since eprinomectin binds extensively to plasmatic proteins, this should be taken into account if it is used in association with other molecules having the same characteristics.

Pour-on use. For single application only.

To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked. If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under- and over- dosing. All the animals belonging to the same group should be treated at the same time. Underdosing could result in ineffective use and may favour resistance development.

The product should be applied topically by pouring along the backline in a narrow strip extending from the withers to the tailhead.

Cattle:

Administer by topical application at the dose rate of 0.5 mg eprinomectin per kg bodyweight, corresponding to the recommended dose rate of 1 ml per 10 kg bodyweight.

Sheep and goats:

Administer by topical application at the dose rate of 1.0 mg eprinomectin per kg bodyweight, corresponding to the recommended dose rate of 2 ml per 10 kg bodyweight.

When administering the product along the backline, part the fleece/coat and place applicator nozzle or bottle spout against the skin.

• Attach the dose dispenser to the bottle.

• Set the dose by turning the top section of the dose dispenser to align the correct bodyweight with the pointer inside the dose dispenser. When bodyweight is between markings, use the higher setting.

• Hold the bottle upright and squeeze it to deliver a slight excess of the required dose as indicated by the calibration lines. By releasing the pressure, the dose automatically adjusts to the correct level. Tilt the bottle to deliver the dose. For the 1 litre bottle: when a 10 mL or 15 mL dose is required, turn the pointer to “STOP” before delivering the dose. The off (STOP) position will close the system between dosing.

• The dose dispenser should not be stored attached to the bottle when not in use. Remove the dose dispenser after each use and replace with the bottle cap.

Connect the dosing gun and draw-off tubing to the back-pack as follows:

• Attach the open end of the draw-off tubing to an appropriate dosing gun.

• Attach draw-off tubing to the cap with the stem that is included in the pack.

• Replace shipping cap with the cap having the draw-off tubing. Tighten the draw-off cap.

• Gently prime the dosing gun, checking for leaks.

• Follow the dosing gun manufacturer’s directions for adjusting the dose and proper use and maintenance of the dosing gun and draw-off tubing.

No signs of toxicity were observed when 8-week old calves were treated at up to 5 times the therapeutic dose (2.5 mg eprinomectin/kg bodyweight.) 3 times at 7-day intervals.

One calf treated once at 10 times the therapeutic dose (5 mg/kg bodyweight.) in the tolerance study showed transient mydriasis. There were no other adverse reactions to the treatment.

No signs of toxicity were observed when 17-week old sheep were treated at doses up to 5 times the therapeutic dose (5 mg eprinomectin/kg bodyweight) 3 times at 14-day intervals.

No antidote has been identified.

Meat and offal: 15 days. Milk: zero hours.

Meat and offal: 2 days. Milk: zero hours

Meat and offal: 1 day. Milk: zero hours